FDA Registration
Active
🇺🇸 United States
Premom Ovulation Test, PMS2-S
Reg #: 3007606081
·
FEI: 3007606081
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WONDFO USA CO., LTD.
- Registration Number
- 3007606081
- FEI Number
- 3007606081
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 890 Remington Blvd
- City
- Bolingbrook
- State
- IL
- ZIP
- 60440
- Country
- US
Owner / Operator
- Firm Name
- Wondfo USA Co., Ltd.
- Operator Number
- 10028951
- Address
- 890 REMINGTON BLVD
- City
- Bolingbrook
- State
- IL
- Postal Code
- 60440
- Country
- US
- Correspondent
- Kunyuan Mao
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2020-12-24 |
Proprietary Names
Premom Ovulation Test, PMS2-S
One Step Ovulation Urine Test Kit
Wondfo USA Co., Ltd., Preview Fertility Combination Tests {Preview Ovulation Test Strip}
The Babydust Method LH Ovulation Test Midstream
The Babydust Method LH Ovulation Test Strip
Easy@Home Ovulation Test (Midstream)
The Babydust Method LH Ovulation Test Cassette
Easy@Home Ovulation Test (Cassette)
Easy@Home Ovulation Test (Strip)
INDICAID OVULATION TEST STRIP
PREGABLE OVULATION & PREGNANCY TEST KIT (PREGABLE OVULATION TEST)
BABYlife Ovulation Test Strip
Establishment Types
Complaint File Establishment per 21 CFR 820.198